Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin

This study has been completed.

Sponsor:

Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT01452568

First Posted: October 17, 2011

Last Update Posted: August 5, 2014

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The aim of this trial was to compare warfarin therapy (target INR of 2.0 to 3.0) against aspirin 150mg daily as antithrombotic therapy for the first three months after BAVR with or without concomitant coronary artery bypass grafting (CABG). The aim was to evaluate thromboembolic complications, bleeding complications and death.

Warfarin daily dosage to obtain an INR in between 2,0 to 3,0. Started the day after surgery and continued for three months.

Other Name: marevan

Study Arms

Experimental: Aspirin

Aspirin 150mg daily, starting day 1 after surgery, for three months.

Intervention: Drug: Aspirin

Active Comparator: Warfarin

Warfarin daily dosage to International normalized ratio(INR) value between 2,0 to 3,0.

Intervention: Drug: Warfarin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

370

Completion Date

March 2012

Primary Completion Date

March 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion criteria:

Patients with aortic valve disease where there is indication for implantation of a biological stented aortic valve with or without coronary bypass surgery.

Age 60 years Sinus rhythm

Exclusion Criteria:

Patients planned for double valve surgery

Patients with active endocarditis

Patients with atrial fibrillation/flutter

Patients in anticoagulation treatment of other reason.

Patients with previous cerebrovascular accidents or insults.

Patients with TCI

Patients with hypercoagulable conditions, disseminated intervascular coagulation, haemophilia or any other blood coagulapathy or related condition, whereby the blood coagulation process is not readily controllable

Patients with pacemaker

Any other disease than valve disease that will considerably increase the operative risk and increase the probability that the patient dies within one year after the operation, for example because of terminal cancer

Patients that is HIV-positive or have active AIDS

Patients that are known drug abuser

Patients in chronic haemodialysis or other types of dialysis

Sex/Gender

Sexes Eligible for Study:

All

Ages

60 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Yes

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects